As per the pharmaceutical pricing policy passed in 2012, any brand of drugs included in NLEM cannot cost more than the weighted average of all brands of that particular medicine that have a market share of at least one per cent.

In a move that could bring relief to thousands of cancer patients, the pharmaceutical pricing authority has recommended the inclusion of 12 drugs used to treat a range of life-threatening conditions, from leukaemia to breast cancer, in the National List of Essential Medicines (NLEM).

If the National Pharmaceutical Pricing Authority (NPPA) recommendation is accepted, these drugs (see box), whose prices range from Rs 3,000 to Rs 8 lakh for treating an average-sized adult, could come under price control.

As per the pharmaceutical pricing policy passed in 2012, any brand of drugs included in NLEM cannot cost more than the weighted average of all brands of that particular medicine that have a market share of at least one per cent.

This means there could be a significant drop in prices where the difference in cost of using the original or “innovator” brand and its generic variants is significant.

For instance, in the case of brain tumours, the current cost of treatment using Temozolomide is Rs 2.16 lakh for the innovator brand and Rs 20,000 for its generic variants.

Again, for Irinotecan, which is used in treating a range of cancers including those in the lungs and ovaries, the cost ranges from Rs 1.87 lakh for innovator brands to Rs 25,000 for the generic ones.

“All of these are widely used and very useful drugs. Bringing them under price control will help a lot of patients,” said Dr P K Julka, professor of oncology, All India Institute of Medical Sciences (AIIMS).

However, an industry representative criticised the move, saying that any form of price control may affect the “availability” of drugs.

“Determining essential medicines is the domain of experts, not of economists and bureaucrats. Enforcing price control may actually end up affecting the availability of these drugs in the long term. State funding of drugs, like in Tamil Nadu and Kerala, is the only viable way forward,” said D G Shah of the Indian Pharmaceutical Alliance, an umbrella organisation for pharma companies.

The pricing authority, meanwhile, has also recommended the deletion of three drugs from NLEM, one whose use dates back to 1959, and two others with limited use in India at present.

They include Busulphan, used before autologous stem cell transplants started, and Raloxifen, used in post-menopausal women for prevention of breast cancer – Danazol is no longer used.

Official sources said the NPPA granted “post-facto approval” to the recommendation in a meeting of the authority on March 25. The recommendation was forwarded to the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilisers some time ago.

According to documents examined by The Indian Express, the pricing recommendation is based on inputs from the Tata Memorial Centre in Mumbai and the pharmaceutical industry from which it had invited feedback last November.

The recommendation has given priority to drugs with a potential for cure, and those that can benefit the maximum number of patients according to data from the national cancer registry programme, the documents show.

They also record that the NPPA kept in mind the non-availability of alternative medications of the same group and the price difference between various brands of the same drug.

According to sources, the meeting in March also discussed another move to include cardiac stents in NLEM following reports of overpricing.

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